• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification

  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Device tester, electrode, surface, electrocardiographic
Regulation Description Electrocardiograph surface electrode tester.
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeKRC
Premarket Review Office of Device Evaluation (ODE)
Division of Cardiovascular Devices (DCD)
Cardiac Diagnostics Devices Branch (CDDB)
Submission Type 510(k)
Regulation Number 870.2370
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Electrocardiograph (ECG) Surface Electrode Tester [http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080228.pdf] 
Third Party Review
Accredited Persons

-
-